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Atorvastatin in Relapsing-Remitting Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborators:
German Research Foundation
German Federal Ministry of Education and Research
Pfizer
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00616187
First received: February 5, 2008
Last updated: February 14, 2008
Last verified: February 2008
History of Changes
  Purpose

A phase II open-label baseline-to-treatment trial was designed to evaluate the safety, tolerability and efficacy of orally administered atorvastatin in patients with relapsing-remitting multiple sclerosis (RRMS). Patients with at least one gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were eligible for the study. Patients are screened and enrolled in the outpatient clinic of the Cecilie Vogt Clinic at the Charité - University Medicine Berlin. After a baseline period of 3 monthly MRI scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg atorvastatin daily. The primary endpoint is the number of CEL in treatment months 6 to 9 compared to baseline. Secondary endpoints include other MRI-based parameters and changes in clinical scores and immune responses.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
 Drug: interferon beta treatment to add-on atorvastatin treatment
Drug: untreated to atorvastatin treatment
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • number of MRI contrast enhancing lesions [ Time Frame: treatment months 6 to 9 compared to baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • other MRI-based parameters (CEL volume, T2-lesion load, T1-hypointense lesion volume, whole brain magnetization transfer ratio, and apparent diffusion coefficient of normal appearing white matter) [ Time Frame: treatment months 6 to 9 compared to baseline ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: October 2003
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: interferon Drug: interferon beta treatment to add-on atorvastatin treatment
IFN-β-1a 22 µg s.c. 3 times weekly or IFN-β-1b s.c. every other day (3 months baseline) and add on oral daily 80 mg atorvastatin (9 months add on treatment)
Sham Comparator: untreated Drug: untreated to atorvastatin treatment
no treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 - 55 years old
  • MS diagnosis according McDonald criteria
  • Relapsing-remitting MS
  • EDSS 0 - 6
  • Disease activity as occurrence of CEL in brain MRI
  • IFN-beta therapy for at least 6 months

Exclusion Criteria:

  • Primary chronic progressive MS
  • Symptoms and signs of clinical disease conditions similar to MS
  • Conditions that can disturb MRI measurements
  • Clinically relevant GI diseases eg Colitis ulcerosa, Crohns disease, history of Ulcus pepticum
  • Clinically relevant lung, heart, CNS, infectious disease
  • Clinically relevant liver, kidney or bone marrow abnormalities (as defined by specific clinical chemistry values)
  • Allergies towards Gd-DTPA
  • Allergies towards constituents of the therapeutic agent
  • Recruitment to other clinical trials within 6 months prior to or during this study
  • Pretreatment with complete lymph irradiation, antibody therapy against lymphocyte populations (eg. anti-CD4, Campath-1H), mitoxantrone, cyclophosphamide, cyclosporin A, human antibodies, all immunomodulatory or immunosuppressive agents including recombinant cytokines or other potential experimental MS therapies (6 months prior to study start), glatiramer acetate, azathioprine, IVIg (6 months prior to study start) pregnancy or lactation
  • Alcohol or drug abuse
  • Inhibitors of Cytochrom P 450 3A (eg. cyclosporin, macrolide antibiotics, azole antimycotics).
  • Medical or psychological conditions that could hamper with the patients capacity to understand patient information, to give the informed consent, to adhere to the protocol of the study and to be able to complete the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616187

Sponsors and Collaborators
Charite University, Berlin, Germany
German Research Foundation
German Federal Ministry of Education and Research
Pfizer
Investigators
Principal Investigator: Frauke Zipp, MD Cecilie Vogt Clinic for Neurology, Charite, Berlin
  More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor Frauke Zipp, Cecilie Vogt Clinic for Neurology, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00616187     History of Changes
Other Study ID Numbers: 1931/Si.270 am 8.5.03, ATV-D-03-007G
Study First Received: February 5, 2008
Last Updated: February 14, 2008
Health Authority: Germany: Federal Ministry for Health and Social Affairs Berlin(LaGeSo Berlin)

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Atorvastatin
Antiviral Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 16, 2013